The Randomized Controlled Cocoa-Appetite Trial

Overview

The purpose of this study is to determine whether high-flavonoid cocoa can decrease appetite in humans. In addition the study is designed to test epicatechin, a compound found in cocoa and procyanidins, a class of compounds found in cocoa, for their ability to decrease appetite in humans.

Full Title of Study: “A Pilot Randomized Human Trial on The Effects of Cocoa on Appetite.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2015

Detailed Description

The study is a four-way randomized double-blinded crossover trial with randomization balanced for beverage and lab visit order.

Interventions

  • Dietary Supplement: Lo-Flav
    • low-flavonoid cocoa powder with 0 mg of procyanidins and 0 mg epicatechin per kg of body weight will be consumed as a beverage.
  • Dietary Supplement: Hi-Flav
    • High-flavonoid cocoa powder with 3.8 mg procyanidins per kg of body weight and 0.6 mg Epicatechin per kg of body weight will be consumed as a beverage.
  • Dietary Supplement: Epicatechin
    • Low-flavonoid cocoa powder plus 1 mg epicatechin per kg of body weight will be consumed as a beverage
  • Dietary Supplement: Procyanidins
    • Low-flavonoid cocoa powder plus 3.7 mg procyanidins per kg of body weight will be consumed as a beverage.

Arms, Groups and Cohorts

  • Placebo Comparator: Lo-Flav
    • Low-flavonoid cocoa powder with 0 mg of procyanidins and 0 mg epicatechin per kg of body weight will be consumed as a beverage
  • Active Comparator: Hi-Flav
    • Cocoa powder with 3.8 mg procyanidins per kg of body weight and 0.6 mg Epicatechin per kg of body weight will be consumed as a beverage.
  • Active Comparator: Epicatechin
    • Low-flavonoid cocoa powder plus 1 mg epicatechin per kg of body weight will be consumed as a beverage.
  • Active Comparator: Procyanidins
    • Low-flavonoid cocoa powder plus 3.7 mg procyanidins per kg of body weight will be consumed as a beverage.

Clinical Trial Outcome Measures

Primary Measures

  • Appetite as assessed by amount of pizza eaten.
    • Time Frame: Two and a half hours
    • Amount of pizza eaten to be assessed two and one half hours after ingestion of the beverage.

Secondary Measures

  • Appetite as assessed by a Visual Analog Scale
    • Time Frame: Two and one half hours
    • Visual Analog Scale assessments to be conducted during the two and one half hours after ingestion of the beverage.

Participating in This Clinical Trial

Inclusion Criteria

  • stable-weight, as indicated by weight gain or loss of <2% in the past 6 months; – engaging in only mild exercise< twice a week; – moderate alcohol users, <2 drinks/day; – willing to eat pizza. – mentally and physically healthy. Exclusion Criteria:

  • smokers regular; – frequent drinkers of coffee, tea or cola sodas, >daily; – underweight or obese (BMI: <18.5 or >30 Kg/m2); – allergies to chocolate, cocoa, green tea, coffee or pizza; – using medication; – interested in registering in the future for the course Health & Nutrition Sciences 2140, Introduction to the U.S. Health Care System, that is often taught by the PI of the proposed study

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Brooklyn College of the City University of New York
  • Provider of Information About this Clinical Study
    • Principal Investigator: James Greenberg, Associate Professor, Department of Health & Nutrition Sciences, – Brooklyn College of the City University of New York
  • Overall Official(s)
    • James Greenberg, Ph.D, Principal Investigator, Department of Health & Nutritional Sciences, Brooklyn College of the City University of New York

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